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Carcinogenicity of coumarin with particular reference to the possible mechanism of hepatocarcinogenicity in the rat
Joint COC/COM statement - August 1998

The Joint Food Safety and Standards Group of the Department of Health and the Ministry of Agriculture Fisheries and Food has requested advice on the interpretation of the available carcinogenicity and mutagenicity data on coumarin and whether the substance should be regarded as a genotoxic carcinogen. The toxicology data are under consideration by the Council of Europe’s Committee of Experts on Flavouring Substances (CEFS) as part of its review of flavouring source materials and this committee, of which the UK is a member, has asked for advice from national experts on the genotoxic potential of coumarin.

Coumarin (2H-1-benzopyran-2-one) is present as a major constituent in plants such as tonka beans and as a minor constituent in certain edible fruits such as strawberries, cherries and apricots. It also occurs in natural flavouring source materials such as cinnamon and is also used in fragrances. Limits on coumarin levels in food as a result of its presence in natural flavouring sources are set in Directive 88/388/EEC. These limits, which were recommended by the EU Scientific Committee for Food (SCF), were based on those previously set by the CEFS in its review of natural flavouring source materials.

An extensive review of the toxicology of coumarin was subsequently carried out by the SCF in 1994 which concluded that coumarin was carcinogenic in rats via the oral route and possibly in mice. The SCF considered that the genotoxicity of coumarin could not be ruled out and that the general permitted level in foods and beverages should be reduced from 2 mg/kg to the currently achievable limit of detection (0.5 mg/kg) and action be taken to reduce levels permitted in other specific products. The CEFS is currently considering coumarin again as part of a further toxicological review of natural flavouring source materials and it is for current discussions at this committee that the opinions of the expert committees, the COM and COC, have been sought.

The COM and COC have primarily considered the adequacy of the available mutagenicity data but have also commented on the significance of the data for human health and the possible mechanisms for carcinogenicity documented in rodents.

The COM and COC agreed that there were insufficient data to draw any definite conclusions regarding the mechanism of coumarin-induced carcinogenicity in the rat. It was agreed that in view of the evidence for mutagenic effects in vitro, the first step should be the provision of adequate in vivo mutagenicity data. In this respect adequate rodent bone marrow micronucleus and rat liver UDS assays conducted to the current OECD guidelines were required.

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